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Clean Utilities Engineer

Job description

Clean Utilities Engineer

Sligo

 

What you will do in this Clean Utilities Engineer role:

  • Act as Clean Utility Engineering Subject Matter Expert from the design phase to equipment handover.
  • Review and approve process flow diagrams (PFDs), specifications, layouts and P&ID’s.
  • SME in mechanical, electrical and pneumatic utility systems.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Lead, promote, participate and supervise the implementation and maintenance of the relevant safety programs.
  • Support clean utility equipment installation, integration and coordinate vendor supervision as required.
  • Develop and modify procedures as needed to support the clean utility area.
  • Review and approve process-related commissioning, qualification and validation protocols for completeness and accuracy. Execute protocols on a timely basis to meet the project schedule requirements.
  • Participate in and lead clean utility project implementations.
  • The leadership of clean utility and validation activities during the project life cycle.
  • Investigate process exceptions or equipment malfunction incidents affecting the process.
  • Liaise with internal/external engineering personnel and contract maintenance providers in maintaining, troubleshooting and installing/commissioning equipment.
  • Support the production team, ensuring that utility equipment is maintained to ensure production schedules run efficiently.
  • Present on clean utility area in regulatory inspections ensuring successful outcomes
  • Cross-functional collaboration with QC Micro, Operations, QA and Engineering

 

What you will need in this clean utilities Engineer role:

  • A relevant third level qualification in an engineering, science or technical discipline (Degree Level or Master’s preferable)
  • At least six (5) years of total combined experience in Clean Utility / Equipment or Manufacturing Engineering in Pharma, Biotech or Medical Device Industry.
  • Previous experience in manufacturing biotechnological drugs, parenteral drugs, solutions preparation, fill-finish, Lyophilisation, sterilisation operations preferable. Experience in clean utilities is essential.
  • Knowledge of policies and regulatory requirements ensuring compliance with cGMP and ISO/FDA regulations.

 

If you are interested apply today by sending your CV to Ryant@sigmar.ie

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